"Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA". The New England Journal of Medicine. Published May 16, 2018.
Links to original sources: Wiki Journal Post Full Journal Article
Does the combination of clopidogrel and aspirin improve outcomes compared to aspirin alone in patients with minor ischemic stroke or high-risk TIA?
In patients with minor ischemic stroke or high-risk TIA, the combination of clopidogrel and aspirin reduced the risk of major ischemic events but increased the risk of major hemorrhage at 90 days compared with aspirin alone.
Combination therapy of clopidogrel and aspirin may decrease the recurrence of stroke after minor ischemic stroke or TIA. The POINT trial extended the findings from the CHANCE trial (in a Chinese population) by assessing this combination therapy in a diverse international population.
At the time of the POINT trial publication, guidelines did not routinely recommend combined clopidogrel and aspirin for the treatment of stroke.
- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial - N=4,881 patients - Clopidogrel + aspirin vs. aspirin alone - Enrolment: May 28, 2010, to December 19, 2017 - Follow-up: 90 days
- At least 18 years of age - Had a minor ischemic stroke (NIHSS score ≤3) or high-risk TIA (ABCD2 score ≥4) within 12 hours prior - Underwent imaging to rule out intracranial hemorrhage or other mimics - Major exclusions: Candidates for thrombolysis/thrombectomy, contraindication to aspirin or clopidogrel, anticipated need for NSAID use beyond 7 days
- Clopidogrel (600 mg on day 1, followed by 75 mg per day) + aspirin (50 to 325 mg per day) vs. aspirin alone (same dose range)
- Primary efficacy outcome: Composite of ischemic stroke, myocardial infarction, or death from ischemic vascular causes at 90 days - Major hemorrhage was the primary safety outcome
- Lower-than-expected overall event rates, particularly in TIA patients with low ABCD2 scores - The study population did not represent moderate-to-severe stroke, cardioembolic stroke, or candidates for thrombolysis/thrombectomy
- National Institute of Neurological Disorders and Stroke - Sanofi provided clopidogrel and placebo for 75% of patients
POINT ClinicalTrials.gov number, NCT00991029